Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-06

Study Completion Date

2026-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background:

Functional movement disorders (FMD) involve involuntary movements that are not due to a recognized neurological or medical cause. FMD can cause major disability. Researchers want to learn more to create better treatments for FMD.

Objective:

To test whether non-invasive brain stimulation using transcranial magnetic stimulation (TMS) improves FMD symptoms.

Eligibility:

People between the ages of 18 and 80 who have been diagnosed with FMD by a neurologist.

Design:

Participants will be randomly assigned to one of two groups. One group is an active brain stimulation group and the other is a sham brain stimulation group.

Participants will have a baseline visit. This will include:

Neurological exam

Questionnaires

Urine test

Brain MRI: Participants will lie in a machine that takes pictures of the body. They will be asked to respond to images on a screen while in the scanner.

Within 2 weeks of the baseline visit, participants will begin 5 daily sessions of TMS. The active group will have stimulation delivered to the brain via a coil. In the sham group, a dummy coil will be used that will not deliver stimulation. A total of three 3-minute cycles will be done in one visit. There will be 20-minute breaks between the cycles.

Participants will have visits 1 month, 2 months, and 6 months after their last day of TMS. Their FMD symptoms will be evaluated. They will complete health questionnaires. These visits can be in person or virtual.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transcranial Magnetic Stimulation to Treat Parkinson's Disease

NCT00753519

Parkinson Disease

COMPLETED PHASE1/PHASE2

Trial Of Neurostimulation Treatment and Investigation for Causes of Functional Motor Symptoms: a Pilot Study

NCT05829005

Functional Neurological Symptom Disorder

COMPLETED NA

Theta Burst Transcranial Magnetic Stimulation of Fronto-parietal Networks: Modulation by Mental State

NCT04010461

Healthy

COMPLETED NA

Brain Oscillation-synchronized Stimulation of the Frontal Cortex in Major Depressive Disorder

NCT06345651

Major Depressive Disorder

RECRUITING NA

Non-invasive Brain Stimulation and Injury Risk Biomechanics

NCT06093295

Concussion, Mild

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study Description:

The purpose of this protocol is to investigate efficacy of intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC) in patients with functional movement disorders (FMD). Participants will be randomly assigned to receive either active iTBS or sham stimulation of the left DLPFC for 5 consecutive daily sessions.

Objectives:

Primary Objective: To investigate efficacy of iTBS of the left DLPFC on motor symptoms in patients with FMD

Secondary Objectives: To investigate efficacy of iTBS of the left DLPFC on mood symptoms and its effect on fronto-amygdala circuit on functional neuroimaging

Endpoints:

Primary Endpoint: Relative change in Functional Movement Disorder Rating Scale (S-FMDRS) from the baseline to 1 month after iTBS vs sham: 100 \*( S-FMDRS at one-month - S-FMDRS at baseline)/ S-FMDRS at baseline

Secondary Endpoints:

* S-FMDRS immediately after, 2 months and 6 months after the treatment
* HADS at 1 month, 2 months and 6 months after the treatment
* DLPFC-amygdala functional connectivity
* Amygdala BOLD response to emotional stimuli

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Functional Movement Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Sham TMS stimulation using a sham coil

Group Type SHAM_COMPARATOR

Sham Comparator

Intervention Type OTHER

Sham TMS stimulation using a sham coil

Treatment

Active TMS stimulation using an active TMS coil

Group Type EXPERIMENTAL

MagStim

Intervention Type DEVICE

Bursts of three at 50Hz with an inter burst interval of 200 ms will be given for 190 seconds and this session will be repeated 3 times with 20 minutes between each session in one day. The set of 3 sessions will be repeated 5 times in 5 consecutive days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MagStim

Bursts of three at 50Hz with an inter burst interval of 200 ms will be given for 190 seconds and this session will be repeated 3 times with 20 minutes between each session in one day. The set of 3 sessions will be repeated 5 times in 5 consecutive days.

Intervention Type DEVICE

Sham Comparator

Sham TMS stimulation using a sham coil

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18-80
* Diagnosis of functional movement disorder made by a neurologist
* Agreement to adhere to Lifestyle Considerations throughout study duration
* Ability of subject to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

* Current psychosis or active suicidal ideation
* History of epilepsy with the exception of febrile seizure
* Patients with psychogenic non-epileptic seizure without comcomitant functional movement disorder
* Any significant neurological disorders other than FMD including but not limited to multiple sclerosis, stroke, Parkinson s disease, space occupying brain lesion
* Alcohol or substance use disorder
* Patients who are on Buproprion (Wellbutrin)
* Patients with moderate to severe cardiac disease
* Any psychiatric, medical or social condition due to which, in the judgment of the PI and after any consults if indicated, participation in the study is not in the best interest of the patient.
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No